MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 9F; CHRONIC CATHETERS

Model Number	0600600
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 01/2026.
Event or Problem Description
It was reported that twenty four days post chronic catheter placement, the patient allegedly experienced pain over catheter insertion site and mild swelling was noted under right clavicle area.It was further reported that removal and exchange of catheter was performed to treat pain and swelling.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9fr hickman d/l catheter was returned for evaluation and three electronic photos were provided for review.Gross visual, microscopic visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the identified material hole issue as under microscopic evaluation pinhole was noted on the catheter body, proximal to the tissue cuff.Furthermore, the relation of identified device problem to the reported clinical condition cannot be confirmed due to lack of evidence.Therefore, the clinical conditions alleged in the complaint is inconclusive.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 01/2026).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that twenty four days post chronic catheter placement, the patient allegedly experienced pain over catheter insertion site and mild swelling was noted under right clavicle area.It was further reported that the patient was treated with basic pain management and anti-inflammatory drugs to treat pain.Reportedly that catheter was removed and exchanged to treat pain and swelling.The current status of the patient is unknown.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 9F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16331504
• Report Number: 3006260740-2023-00384
• Device Sequence Number: 20530568
• Product Code: LJS
• UDI-Device Identifier: 00801741051890
• UDI-Public: (01)00801741051890
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0600600
• Device Catalogue Number: 0600600
• Device Lot Number: HUFV1417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown